TEO DR Pacemaker - Dual-chamber pacemaker, rate-responsive

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

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Download 공공 평가 보고서 (PAR)
10-02-2020

제공처:

Microport Crm Pty Ltd

수업:

AIMD

Manufactured by:

MicroPort CRM S.r.l Via Crescentino sn, Saluggia, VC, 13040 Italy

치료 영역:

47265 - Dual-chamber pacemaker, rate-responsive

치료 징후:

TEO DR Pacemaker is DDDR-type dual-chamber rate responsive pacemaker. It is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient?s activity TEO DR Pacemaker is indicated for symptomatic paroxysmal or permanent second- or third-degree AV block; symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; Bradycardia-tachycardia syndrome to prevent symptomatic Bradycardia or some forms of symptomatic tachyarrhythmias, vasovagal syndromes or hypersensitive carotid sinus syndromes. Dual-chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual-chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony. The device(s) are MR Conditional in the 1.5T and 3T MR environment.

승인 상태:

A

승인 날짜:

2019-12-16

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